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Trial · Observational

RecruitingPhase not statedRegistry data

A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

NCTNCT07345494 (opens ClinicalTrials.gov in a new tab)Other idASND0043
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase not stated
Enrollment
50 participants (estimated)
Sponsor
Ascendis Pharma A/S · Industry
Design
Not stated
Countries
1 country

United States

Start
18 Feb 2026
Primary completion
Jan 2036 (estimated)
Completion
Jan 2036 (estimated)
First posted
15 Jan 2026
Last update posted
2 Mar 2026
Conditions
Hypoparathyroidism

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620282030203220342036
  1. Ph –

    A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

    NCT07345494

    18 Feb 2026 to est. Jan 2036

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.

Interventions

  • PalopegteriparatideDrug

Arms1

  • Other

    Palopegteriparatide

    Pregnant women exposed to palopegteriparatide during pregnancy

Primary outcomes12

Outcomes the sponsor listed as primary.

  1. The number of fetuses as reported by HCP

    Time frame · 21 months

  2. Pregnancy outcomes

    Time frame · 21 months

    Registry description

    * Live birth (preterm delivery, full-term delivery) * Spontaneous abortion * Pregnancy termination * Fetal death/stillbirth * Molar or ectopic pregnancy

  3. Number of congenital malformations identified in the developing fetus, neonate, or infant

    Time frame · 21 months

  4. Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)

    Time frame · 21 months

  5. Number of hospitalizations including reasons for hospitalization

    Time frame · 21 months

  6. Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment

    Time frame · 21 months

  7. Number of signs of hypocalcemia or hypercalcemia

    Time frame · 21 months

  8. Descriptive statistics of infant developmental deficiency (CDC 2021)

    Time frame · 21 months

  9. Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)

    Time frame · 21 months

  10. Descriptive statistics of neonatal and infant mortality

    Time frame · 21 months

  11. Maternal complications of pregnancy

    Time frame · 21 months

    Registry description

    Including but not limited to * Premature rupture of membranes (PROM) * Preterm PROM (PPROM) * Pre-eclampsia * Gestational hypertension * Eclampsia * Proteinuria * Gestational diabetes * Intrauterine growth restriction (IUGR) * Polyhydramnios * Preterm delivery * Measures of fetal growth deficiency (e.g., small for gestational age)

  12. Other maternal events of interest

    Time frame · 21 months

    Registry description

    Number of * AEs, including SAEs * Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 15 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participants aged 15 to 50 years * Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and/or during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of \~ 60 hours * Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent/legal guardian will be obtained. Exclusion Criteria: * Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.

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